Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Adverse Drug Reaction related Notifications

S.no Drug Name ADR Detected Release Date Download Pdf Pdf Size
1 Tranexamic Acid Back Pain 2026-Jul-21 475 KB
2 Aceclofenac Fixed Drug Eruption (FDE) 2026-Jul-21 466 KB
3 Tranexamic Acid Back Pain 2026-Jul-21 475 KB
4 Ibuprofen Fixed Drug Eruption 2026-Jul-21 469 KB
5 Vancomycin Dress Syndrome 2026-Jul-06 837 KB
6 Oral Itraconazole Symmetrical Drug Related-Intertriginous and Flexural Exanthema 2026-Jul-06 892 KB
7 Metronidazole Fixed Drug Eruption (FDE) 2026-Jul-06 850 KB
8 Piperacillin + Tazobactam Blurred Vision 2026-Jul-06 854 KB
9 Tetracycline Fixed Drug Eruption (FDE) 2026-Jul-06 842 KB
10 Cotrimoxazole Fixed Drug Eruption (FDE) 2026-Jul-06 845 KB
11 Doxycycline Restlessness, Anxiety, Irritability, Nervousness, and Dizziness 2026-Feb-17 562 KB
12 Carbimazole Agranulocytosis 2026-Feb-17 518 KB
13 Losartan Muscle spasm 2026-Feb-06 614 KB
14 Itraconazole Photosensitivity 2026-Feb-04 768 KB
15 Paracetamol Fixed Drug Eruption 2023-Feb-06 625 KB
16 Piroxicam Fixed Drug Eruption 2023-Feb-06 621 KB
17 Covishield SRP Syndrome GBS 2023-Feb-03 387 KB
18 Covaxin SRP Syndrome GBS 2023-Feb-03 339 KB
19 Oseltamivir Sinus Bradycardia/Bradycardia 2022-Sep-20 635 KB
20 Piperacillin + Tazobactuam Acute generalized exanthematous pustulosis (AGEP) 2022-Sep-20 667 KB
21 Remdesivir Sinus bradycardia 2022-Sep-20 625 KB
22 Tigecycline Coagulopathy 2022-Sep-20 623 KB
23 Cephalosporins Fixed Drug Eruption 2022-Sep-20 649 KB
24 Haloperidol Cogwheel rigidity 2022-Jul-04 604 KB
25 Mannitol Hypokalaemia 2022-Jun-24 596 KB
26 Mefenamic acid Fixed Drug Eruption 2022-Jun-14 609 KB
27 Docetaxel Candidiasis 2022-Jun-14 594 KB
28 Tramadol Urinary Retention 2022-Jun-14 602 KB
29 Olanzapine Hyponatraemia 2022-Jun-04 601 KB
30 Pulmonary Surfactant Pulmonary Haemorrhage 2022-May-13 642 KB
31 Ceftriaxone Stevenson Johnson Syndrome 2022-Feb-04 768 KB
32 Amoxicillin/Clavulanate Stevenson Johnson Syndrome SJS/Toxic Epidermal Necrosis (TEN) 2022-Feb-04 768 KB
33 Azithromycin Acute generalized Exanthematosus Pustulosis 2022-Feb-04 768 KB
34 Ciprofloxacin Stevenson Johnson Syndrome SJS/Toxic Epidermal Necrosis (TEN) 2022-Feb-04 768 KB
35 Cloxacillin Acute generalized Exanthematosus Pustulosis 2022-Feb-04 768 KB
36 Dipeptidyl Peptidase-4 (DPP4) Inhibitors like Sitagliptin, Vildagliptin, Saxagliptin etc. Arthralgia 2022-Feb-04 768 KB
37 Ibuprofen Stevenson Johnson Syndrome (SJS)/ Toxic Epidermal Necrosis (TEN) 2022-Feb-04 768 KB
38 Ranitidine Cardiac arrest 2022-Feb-04 768 KB
39 Tinidazole Fixed Drug Eruption (FDE) 2022-Feb-04 768 KB
40 Lamotrigine Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) 2021-Nov-09 660 KB
41 Benidipine Photosensitivity reaction 2021-Mar-09 629 KB
42 Alfuzosin Palpitation 2021-Mar-09 617 KB
43 Pentoxifylline Palpitation 2021-Mar-09 625 KB
44 Chloroquine SJS-TEN 2020-Jan-30 66 KB
45 Lamivudine Hearing Loss 2020-Jan-13 62 KB
46 Proton Pump Inhibitor Acute Kidney Injury 2019-Nov-04 1064 KB
47 Diclofenac Nicolaus syndrome 2019-Jul-24 971 KB
48 Meropenem Hypokalemia 2019-Jun-19 752 KB
49 CarbamazepineD Drug Rash with Eosinophilia and Systemic Symptom (DRESS)t 2019-Jun-19 916 KB
50 Artemether + Lumefantrine Steven Johnson Syndrome (SJS)a 2019-Jun-19 874 KB
51 Phenobarbital Drug Rash with Eosinophilia and Systemic Symptom (DRESS)1 2019-Jun-16 928 KB
52 Amlodipine Gingival Hypertrophy 2019-Jun-13 990 KB
53 Carvedilol Hyperkalemia 2019-Jun-13 735 KB
54 AmlodipineA Alopecia 2019-Jun-13 1015 KB
55 Cefepime Urticaria 2019-Jun-12 872 KB
56 Sulfasalazine(SJS) Steven Johnson Syndrome(SJS) 2019-Jun-12 766 KB
57 Sulfasalazine(TEN) Toxic Epidermal Necrolysis(TEN) 2019-Jun-12 895 KB
58 Terbinafine Acute Generalised Exanthematous Pustulosis (AGEP) 2019-Jun-12 1061 KB
59 Fluconazole Hyperpigmentation 2019-Jun-12 430 KB
60 Sodium Valproate Gum Hyperplasia Adverse Reaction 2019-Apr-09 923 KB
61 Cefixime Acute Generalised Exanthematosus Pustulosis (AGEP) 2019-Apr-09 694 KB
62 Cefotaxime Angioedema Adverse Reaction 2019-Apr-09 759 KB
63 Ofloxacin Steven Johnson Syndrome(SJS)/ Toxic Epidermal Necrolysis(TEN 2019-Apr-09 982 KB
64 Quetiapine Urinary incontinence 2019-Apr-09 859 KB
65 Sulfasalazine Drug Rash with Eosinophilia and Systemic Symptom (DRESS) 2019-Apr-09 795 KB
66 Anti-Rabies vaccine Erythema Multiforme 2016-Oct-04 1792 KB
67 FDC of Piperacillin and Tazobactam Hypokalaemia, Bronchospasm 2015-Dec-23 2347 KB
68 Carbamazepine Steven Johnson Syndrome(SJS)/ Toxic Epidermal Necrolysis(TEN) 2015-May-12 2371 KB